The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Aft System Iii.
| Device ID | K830214 |
| 510k Number | K830214 |
| Device Name: | AFT SYSTEM III |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | CALBIOCHEM-BEHRING CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-24 |
| Decision Date | 1983-03-09 |